EUCTR2005-002249-38-ES进行中（未招募）不适用
A PHASE 1B DOSE ESCALATION/PHASE 2 RANDOMIZED, NON-COMPARATIVE, MULTIPLE CENTER, OPEN LABEL STUDY OF CP-751,871 IN COMBINATION WITH PACLITAXEL AND CARBOPLATIN AND OF PACLITAXEL AND CARBOPLATIN ALONE AS FIRST LINE TREATMENT FOR ADVANCED NON SMAL CELL LUNG CANCER
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer S.A.
- 入组人数
- 156
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Histologically or cytologically documented NSCLC.
- •2.NSCLC with documentation of Stage IIIB with a pleural or pericardial effusion or multiple ipsilateral lung nodules, or Stage IV, or recurrent disease
- •3.For Phase 2 only: Measurable disease defined by at least one lesion that can be accurately measured and whose size is 2 cm by conventional radiologic techniques or 1 cm by spiral CT scan.
- •4.Adequate bone marrow, hepatic, renal, and cardiac function documented within 14 days prior to enrollment/randomization (see study protocol for further details)
- •5.Age at least 18 years.
- •6.ECOG performance status of 0 or 1 (Appendix F)
- •7.Females must be either: not of childbearing potential (surgically sterilized or at least two years postmenopausal) or if of childbearing potential using an adequate method of contraception,
- •8.Written and voluntary informed consent.
- •9.Life expectancy at least 3 months
- •10.Adequate IV access
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Any prior treatment for NSCLC including chemotherapy, biologic response modifiers or therapy with any investigational agents including previous adjuvant or neoadjuvant chemotherapy.
- •2.Inadequate renal, liver or bone marrow function within 14 days prior to enrollment.
- •3.Gastrointestinal abnormalities including active gastrointestinal bleeding, unrelated to cancer,
- •4.Symptomatic brain metastases. Brain metastases stable for <2 weeks before dosing or requiring concurrent steroid therapy or with clinical symptoms.
- •5.A serious uncontrolled medical disorder or active infection, which would impair their ability to receive study treatment. History of HIV(screening test not required).
- •6.Significant active cardiac disease including: uncontrolled high blood pressure, unstable angina, uncompensated congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac ventricular arrhythmias.
- •7.Patients who are receiving chronic steroid therapy.
- •8.Neuropathy greater than grade 1 or evidence of unstable neurological symptoms within the past 4 weeks.
- •9.Concurrent use of growth hormones or growth hormone inhibitors or aminoglycoside antibiotics.
- •10.Known or suspected hypersensitivity to agents that contain Cremophor® (polyoxyethylated castor oil) in their formulation or mannitol. Medical contraindications to any of the pre-medications required for paclitaxel infusion.
- •11.A history of an active malignancy (other than NSCLC) during the last 3 years except non-melanomatous skin cancer or in situ breast or cervical cancer. Breast cancer prevention treatment with hormonal agents will be permitted.
- •12.Major surgical procedure within 4 weeks of study drug administration. Local radiation within 1 week of study drug administration.
- •13.Dementia or significantly altered mental status
- •14.Women who are pregnant or breast-feeding. WOCBP or fertile males not using an adequate method of birth control. (See Inclusion 7).
研究者
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